Therapeutic Optimism and Informed Consent in Phase I Oncology Trials

Main Article Content

Pramod Lad Rebecca Dahl

Abstract

Therapeutic optimism can be defined as the belief on the part of research subjects that they are more likely to receive a benefit and less likely to experience risk than others who are similarly situated. It can be distinguished from other forms of therapeutic misunderstanding including therapeutic misconception and therapeutic misestimation. Empirical evidence from subjects who participated in phase 1 oncology trials indicates that therapeutic optimism is high in a significant percentage of these subjects. The phenomenon of the optimistic bias (overestimation of benefit and underestimation of risk) underlies the therapeutic optimism. Among the risk factors that may dispose a subject to optimistic bias is the factor of perceived controllability in which the very act of consent may inform the optimism. Two theories in social psychology may be useful in explaining the optimistic bias. These are Gollwitzer’s mindset theory and Kahneman’s fast and slow thought system theory. According to these theories the implementation mindset and the fast thought system may in part explain the optimistic bias. Application of these theories to the informed consent process and using the empirical evidence derived from subjects in phase 1 oncology trials, a hypothesis is offered that the decision to participate in such trials is accompanied by an active rejection of the risk content of informed consent and occurs early in the informed consent process. Exploitation of the optimistic bias and steps that may be taken to curb this exploitation are discussed.


 

Article Details

How to Cite
LAD, Pramod; DAHL, Rebecca. Therapeutic Optimism and Informed Consent in Phase I Oncology Trials. Medical Research Archives, [S.l.], v. 5, n. 11, nov. 2017. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/1607>. Date accessed: 29 mar. 2024. doi: https://doi.org/10.18103/mra.v5i11.1607.
Section
Research Articles

References

Agrawal M, Grady C Fairclough DL
Patients’ decision making process regarding participation in phase I oncology research
Journal of clinical oncology. 2008 ; 24(7):4479-4484.
[PMID: 16983117]

Applebaum PS, Lidz CW, Grisso, T
Therapeutic misconception in clinical research
IRB. 2004; 26(2): 1-8.
[ISSN:0193-7758]

Brandstatter V and Frank E
Effects of deliberative and implemental mindsets on persistence in goal directed behavior
Personality and Social Psychology Bulletin. 2002; 28(10):1366-1378.
[ISSN:0146-1672]

Cox AC, Fallowfield LJ, Jenkins VA
Communication and informed consent in phase I trials: a review of the literature
Support Care Cancer.2006; 14:303-309.
[PMID: 16633840]

Daugherty C, Ratain M, Grochowski E
Perceptions of cancer patients and their physicians involved in phase I trials.
Journal of Clinical oncology. 1995; 13(5):1062-1072.
[PMID: 7738612]

Davidson K and Prkachin K
Optimism and Unrealistic Optimism Have an Interacting impact on health promoting behavior and knowledge changes.
Personality and Social Psychology Bulletin. 1997; 23(6):617-625.
[ISSN:01461672]

Gollwitzer P
Why we thought that action mind-sets affect illusions of control.
Psychological inquiry. 2003;14(3):261-269.
[ISSN:1047-840X]

Gollwitizer PM and Kinney RJ
Effects of Deliberative and implemental mind-sets on illusion of control
Journal of Personality and Social psychology.1989; 56(4): 531-542.

Henderson G , Churchill LR and Davis A.M.
Clinical trials and medical care : defining the therapeutic misconception.
Plos medicine. 2007;4(11) :1735-1738.
[PMID: 18044980]

Harris P
Sufficient grounds for optimism: The relationship between perceived controllability and optimistic bias.
Journal of Social and Clinical Psychology. 1996;15(1): 9-52.
[ISSN:07367236]

Harris P, Griffin D and Murray S
Testing the limits of optimistic bias
Journal of Personality and Social Psychology.2008; 95(5): 1225-1237.
[ISSN:0022-3514]

Horstmann E, McCabe MS and Gochow L
Risks and benefits of phase I oncology trials 1991 through 2002
NEJM. 2005; 352 (9):895-904
[PMID: 15745980]

Horng S and Grady C
Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation and therapeutic optimism
IRB. 2003; 251: 11-16.
[PMID: 12833900]

Horng,S, Emanuel EJ, Wilfond ,B
Descriptions of benefits and risks in consent forms for phase I oncology trials.
N.Eng.J.Med. 2002; 347(26):2134-2140.
[PMID: 12501226]

Jansen LA
The optimistic bias and illusions of control in clinical research
IRB.2016; 38(2): 8-14.
[PMID: 27188031]

Jansen LA
Mindsets ,informed consent and research
Hastings Center report. 2014; 44(1):25-32.

Jansen LA
Two concepts of therapeutic optimism
J Med Ethics. 2011; 37(9):563-566.
[PMID: 21551464]

Jansen LA
The problem with optimism in clinical trials
IRB.2006; 28(4):13-19.
[PMID: 17036434]

Jansen LA, Appelbaum PS and Klein WM
Unrealistic optimism in early-phase oncology trials
IRB. 2011; 33(1):1-8.
[PMID: 21314034]

Jansen LA, Mahadevan D and Appelbaum Ps
The impact of unrealistic optimism on informed consent in early phase clinical trials.
IRB. 2016a;38(5):1-7.
[ISSN:0193-7758]

Jansen LA , MahadevanD and Appelbaum PS
Dispositional optimism and therapeutic expectations in early phase oncology trials.
Cancer.2016b; 122(8):1238-1246.
[PMID: 26882017]

Kahneman D
Thinking Fast and Slow New York; Farrar Strauss and Giroux 2011

Klein C and Helwig-LarsonM,
Perceived control and the optimistic bias , a meta-analytic review
Psychology and Health.2001; 17(4):437-446.
[ISSN:0887-0446]

Kimmelman J
The therapeutic misconception at 25
Hastings Center report. 2007;37(6):36-42.
[ISSN:0093-0334]

Langer E
Illusions of control
Journal of Personality and social psychology.1975; 32(2):311-328.
[ISSN:0022-3514]

Lidz CW, Appelbuam PS and Grisso, T
Therapeutic misconception and the appreciation of risks of in clinical trials
Social Science and Medicine.2004; 58: 1689-1697.
[PMID: 14990370]

Martin A.R.
Hope and Exploitation
Hastings center report. 2008;38(5):49-55.
[PMID: 18947141]

Menikoff J
The vulnerability of the very sick
J.Law Med.Ethics. 2009; 37(1):51-58.
[PMID:19245602]

Meropol NJ, Weinfurt KP, Burnett, CB
Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication.
Journal of Clinical Oncology.2003; 21(13): 258-2596.
[PMID: 12829680]

Miller FG and Joffe S
Benefit in phase I oncology trials
Clinical Trials. 2008; 5(6):617-623.
[PMID: 19029210]

Pentz RD, White M, Harvey RD
Therapeutic misconception, misestimation and optimism in participants enrolled in phase I trials.
Cancer.2012; 118(18):4571-4578.
[PMID: 22294385]

Perreira J , Hanson J, and Bruera, E
The frequency and clinical course of cognitive impairment in patients with terminal cancer.
[Cancer.1997; 79(4): 835-842]

Radcliffe NM and Klein WM
Dispositional, unrealistic and comparative optimism
Personality and Social Psychology Bulletin.2001; 28(6):836-846.
[ISSN:0146-1672]

Schaeffer MH, Krantz DS and Wichman A
Impact of disease severity on the informed consent process in clinical research.
Am J Med. 1996;100:261-268.
[PMID: 8629670]
Schutta KM and Burnett CB
Factors that influence a patient’s decision to participate in a phase I cancer clinical trial.
Oncology Nursing Forum. 2000; 27(9): 1435-1438.
[PMID: 11058975]

Scott J
Therapeutic Misconceptions and Misestimation in Oncology: A clinical trial nurse’s guide.
Clinical Journal of oncology Nursing.2013; 17(5): 486-489.
[PMID: 24080047]

Sekowski D and Barnbaum D
The gambler’s Fallacy, the therapeutic misconception and Unrealistic optimism
IRB. 2013; 35(2):1-6.
[PMID: 23672144]
ISSN:0022-3514.

Sheppard JA, Klein WM and Waters,EA
Taking stock of unrealistic optimism
Perspectives in Psychological Science. 2013 ;8(4):395-411.
[ISSN:1745-6916 (Print)]

Sheppard JA, Waters EA and Weinstein ND
A primer on unrealistic optimism
Current directions in Psychological Sconce.2015; 24(3):232-237.
[ISSN:0963-7214]

Sulmasy DP, Astrow AB, Kai-He, M
The culture of faith and hope : Patients’ justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.
Cancer. 2010; 116(15):3702-3711.
[PMID: 20564120]

Taylor SE and Gollwitzer PM
Effects of Mindset on positive illusions
Journal of Personality and Social Psychology.1995; 69(2):213-226.
[PMID: 7643303]
ISSN:0022-3514.

Von Hoff DD and Turner J
Response rates, duration of response and dose response effects in phase I studies of antineoplastics..
Invest New Drugs.1991; 9 (1) : 115-122.
[PMID: 1827432]

Weinfurt K ,Seils DM,Tzeng JP
Research participants’ high expectations of benefit in early phase oncology trials.
Journal of Clinical Oncology. 2012;30(35):4396-4400.
[PMID: 23091107]

Weinfurt KP ,Seils,DM, Tzeng,JP
Expectations of benefits in early phase clinical trials: Implications for assessing the adequacy of informed consent.
Medical Decision Making. 2008; 28(4):575-581.

Weinstein ND
Unrealistic optimism about future life events
Journal of Personality and Social Psychology.1980; 39(5):806-820.
[ISSN:0022-3514]

Weinstein ND
Why it won’t happen to me
Health Psychology. 1984; 3(5):431-457.
ISSN:0278-6133.
[PMID: 18378940]

Weinstein ND
Optimistic biases about personal risks
Science.1989; 246: 1232-1233.
[ISSN:0036-8075]

Wood S , Hagger LE, McCormack, P
Therapeutic misconception: Hope, Trust and Misconception in pediatric research
Health Care Anal. 2014; 22:3-21.
[ISSN:1065-3058]